Active clinical trials for "Myopia"

The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.

STABLE is a stepped-wedge cluster randomised controlled trial and its primary aim is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among eligible motorcycle drivers in Vietnam as measured under naturalistic driving conditions with the Data Acquisition System (DAS). STABLE is designed to assess the impact of vision correction on the safety of road users in a a Low and Middle income countries (LMIC) setting. A positive trial outcome would demonstrate the safety benefits of vision correction and would create pressure for tighter regulation of drivers' vision and the promotion of vision correction. The study will be conducted in the peri-urban universities in Ho Chi Minh City, Vietnam and 875 students from five universities will be recruited into the trial. Before conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary. Duration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection. Study participants can be both male and female motorcycle drivers aged 18 to 25 years years with at least one year of driving experience; they must use their motorcycle as their primary means of transport; drive at least 50 km per week and present with un- or under-corrected myopia that can be corrected with spectacles. Participants with any ocular or systemic abnormality affecting vision, other than un-or under-corrected myopia will be excluded from the trial. STABLE's primary outcome is CNC events per 1,000 km driven the DAS mounted to the motorcycles of trial participants. An interim analysis of the primary outcome will take place 9 months after data collection begins. The interim analysis will be reviewed by the trial's Data Monitoring and Ethics Committee. Unless a change is needed because of this review, the trial's primary analysis will take place 18 months after the DAS units are fitted to participants' motorcycle). Best-corrected visual acuity and compliance with study glasses; self-reported visual function (driving-adapted Visual Function Questionnaire-25 [VFQ-25]); Dula Dangerous Driving Index (DDDI), maximum abbreviated injury score (MAIS) for all crashes; self-reported CNC events for comparison with recorded CNC events and total delivery cost per CNC event avoided with the intervention (indicator of cost-effectiveness).

Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM, cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week, 36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of NITM and its possible association with the progression of refractive change in Chinese myopic children.

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses.

Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

1.1 Research objectives A．To observe the fundus changes in the posterior pole (morphology, thickness, asymmetry, blood flow density, etc) with the myopia progression. B．To observe morphological changes in choroid and peripheral region of retina with myopia progression. C. To observe changes of visual function (contrast sensitivity, Microperimetry, etc) with myopia progression. D. To detect the susceptibility genes related to high myopia and myopic fundus changes; to test the levels of Vitamin D, riboflavin, transforming growth factor（TGF）, insulin-like growth factor（IGF）, fibroblast growth factor（FGF）, etc. E. To observe the changes of living quality, psychology, behavior and social activities of high myopic children. 1.2 Research design Prospective cohort study. After completing the baseline survey, the planned follow-up frequency is once a year. 1.3 Research cycle 2018.06~2038.06 (at least). 1.4 Expected results A． Registration completed a study of high myopia research for children and adolescents covering around 3,000 people; B． Establish a database information management system and workflow SOP（standard operating procedure）file for the study of high myopia registration in children and adolescents; C． Further clarify the changes in the retinal, choroidal and scleral tissue structures, blood flow density, etc. in the macular area and the optic disc; D． Revealing the changes of the retina, choroid and other tissues in the peripheral area with the progression of myopia; E． To clarify the relationship between changes in the fundus structure and changes in visual function in the posterior pole; F． Further clarify the etiology and pathogenesis of high myopia, pathological myopia and myopic fundus lesions, and identify the relationship between high myopia and pathological myopia; G． From the perspectives of society, behavior and psychology, the effects of high myopia and pathological myopia on children and adolescents will be fully demonstrated. 2. Research object 2.1 General characteristics of the research object Based on the refraction development archive system that has been constructed in Shanghai, the list of children and adolescents with high myopia was selected from the database of children's refractive development archives information in Shanghai. Children of different ages with high myopia must meet the following conditions: 4-5 years old, equivalent spherical error(SE) ≤ -4.0 diopter(D）; 6-8 years old, equivalent spherical error(SE) ≤ -6.0 diopter(D）; 9-18 years old, equivalent spherical error(SE) ≤ -8.0 diopter(D）. 2.2 Sample size A total of 1.25 million children and adolescents are currently registered, 4,006 (0.32%) of which meet the entry requirements. Among the 4~5 year olds, there are 815 people with SE≤-4D; 842 people with SE≤-6 D among the 6~8 year olds; 2349 people with SE≤-8D among the people aged 9 and over . Taking into account the 50% non-response and the proportion of the exclusion, the initial registration number is about 2,000. 2.3 Source of study object Children and adolescents who meet the inclusion criteria in the Shanghai Children's Refractive Development Archives Information Database System.

The last decades have seen a significant increase in myopia in children and young adults. Possible cause: increased near-work (school, computer, smartphone). Rationale: Reading glasses support the accommodative effort of the eyes. By wearing reading glasses, there is less interference with the young eye´s physiological axial growth despite increased near-work. Main objective: does the use of reading glasses during near-work in children and adolescents reduce the incidence of myopia.

Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.

The purpose of this clinical trial is to evaluate the effect of light-emitting diodes (LEDs) with a continuous spectrum of 430-780 nm for lighting in the classroom on myopia prevention among children in Grades 2 and 3.